Study of SPG302 in Adults With Schizophrenia

NCT06442462 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: SPG302-SCZ-201
• Study Type: interventional
• Target: 32
• Locations: 2 countries
• Sites: 3

Brief Summary

This Phase 2 study described herein will evaluate the safety, efficacy, tolerability, and pharmacodynamics of SPG302 in adults with a primary diagnosis of schizophrenia.

Conditions

Schizophrenia

Keywords

synaptogenesis; synapse; dendritic spines

Outcome Measures

Primary Outcomes (3)

• Positive and Negative Symptoms Scale (PANSS Score) as determined by clinician

  The PANSS is a scale to measure symptom severity of schizophrenia. Thirty symptoms of schizophrenia are evaluated by a clinician on a seven point sale, with 1 = absence of symptoms and 7 = extremely severe symptoms. This study will rate each score change by calculating the difference between baseline scale and completion of study intervention.

  6 weeks

• Electroencephalogram analysis to assess brain electrical activity

  Electroencephalograms (EEG) will provide a non-invasive measurement of brain activity. This test will be used to measure specific brain responses to stimuli, including attention and decision making electrical activity and detection of unexpected changes in the auditory environment.

  6 weeks

• Change in smooth pursuit eye tracking from baseline

  Participants will follow visual targets on a computer screen to assess for accuracy of following the item, and smoothness of eye movements. The visual target on the computer screen will follow several different tracking patterns and at various speeds.

  6 weeks

Secondary Outcomes (5)

• Safety and tolerability of SPG302 in patients with schizophrenia

  6 weeks

• Change in Global Impressions Improvement scale as determined by clinician

  6 weeks

• Change in MATRICS Consensus Cognitive Battery scale as determined by clinician

  6 weeks

• World Health Organization Quality of Life - Abbreviated Assessment Questionnaire-brief version from baseline

  6 weeks

• Change in Personal and Social Performance from baseline

  6 weeks

Study Arms (2)

Active SPG302 to be administered to participants with Schizophrenia

ACTIVE COMPARATOR

Participants with schizophrenia will be randomized to receive SPG302 300 mg or placebo (two capsules of 150 mg) once daily for six weeks.

Drug: SPG302

Placebo comparator to be administered to participants with Schizophrenia

PLACEBO COMPARATOR

Participants with schizophrenia will be randomized to receive SPG302 300 mg or placebo (two capsules of 150 mg) once daily for six weeks.

Drug: Placebo

Interventions

SPG302 DRUG

small synthetic molecule

Active SPG302 to be administered to participants with Schizophrenia

Placebo DRUG

Placebo

Placebo comparator to be administered to participants with Schizophrenia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65
• Primary diagnosis of schizophrenia
• Clinical laboratory values within normal range or \< 1.5 times ULN
• Currently prescribed only one antipsychotic medication, with stable dose for at least 4 weeks
• Able and willing to provide written informed consent

You may not qualify if:

• Any physical or psychological condition that prohibits study completion
• Known cardiac disease
• Active or history of malignancy in the past 5 years
• History of clinically significant CNS event or diagnosis in the past 5 years.
• Receipt of investigational products within 30 days
• Blood donation within 30 days

Sponsors & Collaborators

• Spinogenix: lead

Study Sites (3)

CenExel CNS

Garden Grove, California, 92845, United States

Location

Box Hill Hospital - Eastern Health

Box Hill, Victoria, 3128, Australia

Location

Multidisciplinary Alfred Psychiatry Research Centre (MAPrc)

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• David Walling, MD

  CenExel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 4, 2024
• Study Start: August 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2025-07

Locations

US (1); AU (2)